OR WAIT 15 SECS
Offices of Regulatory Affairs and Criminal Investigation Kept Busy
ROCKVILLE, MD-The Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA) and Office of Criminal Investigation (OCI) reported record high numbers of recalls and detentions of potentially hazardous products, criminal convictions, and fines for the 1999 fiscal year. Contributing to the total 3,736 recalls were 1,295 non-compliant blood and blood products and 1,263 medical devices. The FDA detained 41,474 import shipments, almost half of which contained fresh produce and food deemed unsafe or in violation of FDA standards. The ORA conducted 15,161 facility inspections and consequently issued over 7,000 noncompliance lists and 900 warning letters. In addition, eight injunctions were conducted one of which resulted in a record payment of $100 million for a civil violation of public health laws. Not to be outdone, the OCI won 211 court convictions breaking all records set since its inception seven years ago.